FDA Adverse Event Malfunction Summary report: N

SURESCAN

MDR report key: 6046743 · Received October 21, 2016

Report

Report Number: 3004209178-2016-22260
Event Type: Malfunction
Date Received: October 21, 2016
Report Date: November 9, 2016
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL REVIEW INDICATED DEVICE CODE IS NO LONGER APPLICABLE TO THE EVENT. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377760, LOT# V002823, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 399930, LOT# V003188, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

A HEALTHCARE PROFESSIONAL REPORTED THE PATIENT NEEDED AN MRI OF THE THORACIC SPINE DUE TO A PROBLEM WITH THE DEVICE OR THERAPY. IT WAS UNKNOWN IF THE PATIENT'S LEAD WAS CAPPED OR REMOVED. NO PATIENT SYMPTOMS WERE REPORTED AND THE DEVICE WAS INDICATED FOR SPINAL PAIN.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S HEALTHCARE PROVIDER (HCP) REPORTED THAT THERE WAS NO PROBLEM WITH THE DEVICE OR THERAPY. THE PATIENT WANTED AN MRI PADDLE LEAD TO USE WITH THEIR DEVICE, SO THEIR OLDER PERCUTANEOUS LEADS WERE REMOVED PRIOR TO THE MRI SCAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
699601	SURESCAN	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC PUERTO RICO OPERATIONS CO.	97713

Patients

Seq	Age	Sex	Outcome	Treatment
1